Diagnostic radio frequency identification sensors and applications thereof

ABSTRACT

An integrated passive wireless chip diagnostic sensor system is described that can be interrogated remotely with a wireless device such as a modified cell phone incorporating multi-protocol RFID reader capabilities (such as the emerging Gen-2 standard) or Bluetooth, providing universal easy to use, low cost and immediate quantitative analyses, geolocation and sensor networking capabilities to users of the technology. The present invention can be integrated into various diagnostic platforms and is applicable for use with low power sensors such as thin films, MEMS, electrochemical, thermal, resistive, nano or microfluidic sensor technologies. Applications of the present invention include on-the-spot medical and self-diagnostics on smart skin patches, Point of Care (POC) analyses, food diagnostics, pathogen detection, disease-specific wireless biomarker detection, remote structural stresses detection and sensor networks for industrial or Homeland Security using low cost wireless devices such as modified cell phones.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application60/539,419, filed on Jan. 27, 2004, which is incorporated herein byreference in its entirety.

TECHNICAL FIELD

The present invention generally relates to radio frequencyidentification (RFID) tags, and more specifically to a system havingRFID tags that include diagnostic sensors, wherein the RFID tag andsensor are accessible by a wireless device such as a modified cell phonewith a multi-protocol reader capability.

BACKGROUND

The conventional radio frequency identification (RFID) tag systemsinclude an RFID tag that transmits data for reception by an RFID reader(also referred to as an interrogator). In a typical RFID system,individual objects (e.g., store merchandise) are equipped with arelatively small tag that contains a transponder. The transponder has amemory chip that is given a unique electronic product code. The RFIDreader emits a signal activating the transponder within the tag throughthe use of a communication protocol. Accordingly, the RFID reader iscapable of reading and writing data to the tag. Additionally, the RFIDtag reader processes the data according to the RFID tag systemapplication. Currently, there are passive and active type RFID tags. Thepassive type RFID tag does not contain an internal power source, but ispowered by radio frequency signals received from the RFID reader.Alternatively, the active type RFID tag contains an internal powersource that enables the active type RFID tag to possess greatertransmission ranges and memory capacity. The use of a passive versus anactive tag is dependent upon the particular application.

Accordingly, RFID tag systems have found use in a variety ofapplications. RFID tag system applications include animalidentification, beer keg tracking, and automobile key-and-lock,anti-theft systems. Although the conventional RFID tag systems have beenused in a variety of applications, the conventional systems have severaldisadvantages.

A first disadvantage includes the inability of a RFID reader tocommunicate through the use of multiple protocols. In particular, theconventional RFID reader is capable of reading only those RFID tags thatthe RFID reader is programmed to read. That is, the RFID reader isadapted to communicate only through the use of a pre-programmedprotocol. Consequently, the conventional RFID readers are incapable ofautomatically updating or changing protocols. Thus, the current RFIDreaders are unable to communicate with RFID tags having a comunicationprotocol that differs from the RFID reader pre-programmed protocol. Asecond disadvantage includes the inability to conveniently monitorobjects containing the RFID tag from virtually any location. A thirddisadvantage of conventional RFID tag systems is the inability ofwireless devices, such as cellular telephones and personal digitalassitants (PDAs), to be used as RFID readers/interrogaters. The abilityto interrogate RFID tags with conventional wireless devices wouldprovide a convenient method of accessing and/or analyzing data obtainedthrough the use of the RFID tag. Yet another disadvantage is thatconventional RFID tag systems are incapable of cost effective, efficientand convenient monitoring of the physical, biological, and chemicalcharacteristics of a person. For example, the conventional systems donot enable the detection of given biomarkers, pathogens, chemicals orother hazards, near or experienced by a person.

The embodiments described herein were developed in light of these andother disadvantages of known RFID tag systems.

BRIEF SUMMARY

This invention is directed to a system and method for low cost wirelessdiagnostics using modified radio frequency identification (RFID) tagsthat are combined with novel types of diagnostic sensors. A furtheraspect of this invention is that the diagnostic sensors can be read andanalyzed on the spot by low cost wireless devices such as modified cellphones that incorporate multi-protocol RFID reader and communicationstandards such as Gen-2. The technology allows a modified cell phone tobe used to directly identify external threats or to perform almost anytype of diagnostic test on a single platform using low cost disposablepassive RFID-sensors. The reader capabilities of a modified personalwireless device may also include other reader protocols such asBluetooth, Zigbee or IEEE 1073 and read virtually any type of active orpassive sensors, resulting in a new class of wireless readers that aretruly universal and flexible to control virtually any application orprovide a means for analyzing any type of sensor, including diagnosticsensors.

Accordingly, a diagnostics system is disclosed that includes a flexiblepatch having an adhesive portion that is adapted to be positioned on asurface. A radio frequency identification (RFID) tag and sensor moduleis integrated with the patch. The RFID tag and sensor module includes atleast one antenna, an RFID electronic chip, and at least one sensor. TheRFID tag may be either passive or active. Furthermore the technologydescribed here does not need to be limited to RFID and may also beapplied to other wireless interrogation protocols and chip technologiessuch as Bluetooth, Zigbee or other emerging technologies. For the sakeof clarity RFID is used in this patent application but it is understoodthat RFID, Bluetooth, Zigbee or other similar technologies may be usedinterchangeably.

The RFID tag and sensor module responds to a stimulus by wirelesslytransmitting and receiving, through the use of the antenna, signals thatcorrespond to the stimulus. A wireless RFID reader is included that isadapted to communicate, through the use of multiple protocols, with theRFID tag and sensor module. Additionally, the RFID reader is adapted toread and analyze virtually any RFID tag and sensor module. As such, theRFID reader is adapted to retrieve the electronic identification of atag and sensor module and download software that enables reading andanalyses of the tag and sensor from a database. The RFID reader is alsocapable of communicating over a network through the use of multiplecommunication protocols. In one embodiment, the RFID reader is acellular telephone. The diagnostics system may also include a remotestorage/data access unit that remotely stores data transmitted and/orreceived by the RFID tag and sensor module and the RFID reader. A remotewireless device is also disclosed that enables access to the RFID tagand sensor module, the RFID reader, and the remote storage/data accessunit from virtually any location.

Additionally, a method of transmitting and remotely analyzing data froma RFID tag and sensor module is disclosed. The method includes the stepof activating the RFID tag and sensor module through the use of awireless RFID reader. A second step includes receiving data from theRFID tag and sensor module, wherein the data includes RFID tagidentification information. An additional step includes transmitting thereceived data to an external remote storage/data processing unit throughthe use of a network. Yet another step includes processing the datathrough the use of the remote storage/data processing unit. As indicatedabove, in addition to RFID technology, Bluetooth or similar technologymay also be used as an alternative, whereby the cell phone is Bluetoothequipped and may power a remote RF diagnostic sensor that is Bluetoothcompatible.

An immunoassay test strip for use in conducting diagnostic measurementsis also disclosed. The immunoassay test strip includes a substrate andat least one test area located on the substrate for capturing antigens.Additionally, the immunoassay test strip includes a RFID tag and sensormodule integrated with the substrate. The RFID tag and sensor module isadapted to sense and transmit signals that correspond to the antigenscaptured by the at least one test area.

Another method is disclosed for manufacturing a pathogen-specific RFIDtag and sensor module. The method includes the steps of providing asubstrate and printing conductive leads on the substrate, wherein theconductive leads define a sensor area. The method also includes printinga protective cap doped with a material that is sensitive to theenzymatic action within the sensor area. Furthermore, the step ofprinting an antenna on the substrate is included. Accordingly, themethod includes the step of integrating an RFID tag and sensor modulewith the substrate.

An additional feature of this invention is that the wireless devices orthe sensors can also be geolocated anywhere by a global positioningsystem (GPS) and/or non-GPS triangulation means and can be interrogatedremotely through the use of the Internet or by any other wireless devicethat can access a cell phone reader, thereby combining electronicproduct code (EPC) and cellular telephone technologies into a singleplatform.

These and other objects, advantages and features will become readilyapparent in view of the following detailed description of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES

The accompanying drawings, which are incorporated herein and form a partof the specification, illustrate the present invention and, togetherwith the description, further serve to explain the principles of theinvention and to enable a person skilled in the pertinent art to makeand use the invention.

FIG. 1 depicts a block diagram of a modified cell phone serving as anradio frequency identification (RFID) reader with an RFID tag that isembedded in a disposable skin patch according to an embodiment of thepresent invention.

FIG. 2 depicts a block diagram of a disposable fully integrated skinpatch having an RFID tag and sensor module that includes an electronicchip, sensors and an antenna according to an embodiment of the presentinvention.

FIG. 3A is a detailed illustration of the sensor shown in FIG. 2including a chemical/physical barrier.

FIG. 3B is an alternative embodiment of the RFID tag and sensor moduleshown in FIG. 2.

FIG. 3C illustrates a disposable skin patch that is adapted to drawblood from a subject.

FIG. 4 is a system diagram of an RFID diagnostics system for monitoringglucose with a modified cellular telephone that is adapted to read thepatch of FIG. 1.

FIG. 5 is a detailed block diagram of the RFID tag and sensor modulethat includes the electronic chip, the antenna and the sensor of FIG. 2.

FIG. 6 is yet another block diagram of a RFID tag and sensor module.

FIG. 7 depicts a system diagram of a modified cell phone that serves asa RFID reader for a disposable diagnostic flow-through RFID immunoassaystrip.

FIG. 8 is a detailed illustration of the immunoassay strip shown in FIG.7.

FIG. 9 is a detailed illustration of the sensor area of FIG. 8.

FIG. 10 depicts a method of producing a disease-specific disposable RFIDwireless sensor.

FIG. 11 depicts a block diagram of an array of thin-film chemicalsensors printed directly on an RFID substrate according to an embodimentof the present invention.

FIG. 12 depicts the integration of RFID technology with Lab-on-a-Chip(LOC) technology according to an embodiment of the present invention.

FIG. 13 depicts a modified LOC sensor combined with RFID technology thatis read directly with a wireless device such as a cell phone.

FIG. 14 depicts the integration of passive RFID technology with MEMSsensors according to an embodiment of the present invention.

FIG. 15 depicts a wine bottle that includes a cork with a RFID tag andsensor module therein.

FIG. 16 depicts a smart cheese sensor according to an embodiment of thepresent invention.

FIG. 17 depicts a generic low cost printable food-specific RFID sensortechnology according to an embodiment of the present invention.

FIG. 18 depicts a RFID stress sensor according to an embodiment of thepresent invention.

FIGS. 19A and 19B illustrate the use of a RFID tag and sensor module forthe detection of insect infestation within a structure.

FIG. 20 shows a drug interaction test performed in a urine sample with adisposable RFID immunoassay strip according to an embodiment of thepresent invention.

FIG. 21 shows a diagnostic passive RFID sensor network according to anembodiment of the present invention.

FIG. 22 shows an identification (ID) and software retrieval method thatenables any RFID reader to read/interrogate any RFID tag.

FIG. 23 shows the integration of both passive and active sensor readercapabilities onto a single wireless chipset.

DETAILED DESCRIPTION

The technology described herein allows sensor technologies to be coupledto radio frequency identification (RFID) tags that provide both thepower and the wireless interface for the sensor at very low cost.Another aspect of this invention is that common wireless devices such ascell phones can be modified to include the necessary logic andcomponents to become RFID readers. The reader device can furthermoreinclude a multi-protocol RFID reader capability, making it a universalreader for any RFID EPC tag or RFID-sensor tag, regardless of themanufacturer. This technology combination allows on the spotsophisticated processing of complex sensor data at a relatively lowcost. The technology also allows RFID tags or sensor tags to be accessedby the Internet using the wireless reader device as a sensorcommunication tool. Identification retrieval and on the spot softwaredownload into the reader therefore becomes possible. Using this dualtechnology approach, almost any type of sensor can be combined with aRFID tag as described in this application. As will be discussed herein,the sensor is adapted to respond to virtually any stimulus andcommunicate information pertaining to the stimulus wirelessly. Theunderlying principles of the technology are described in more detail inU.S. patent application Ser No. 10/761,362, filed Jan. 22, 2004,entitled, “Radio Frequency Identification Based (RFID) Sensor Networks,”that is incorporated herein by reference in its entirety.

FIG. 1 is a block diagram of a modified wireless device typically acellular phone 2 that includes a microprocessor and the necessary logicto serve as a “power up” and read device for a passive RFID tag that ismounted directly inside a disposable patch 4. As it is made clear inU.S. patent application Ser No. 10/761,362, filed Jan. 22, 2004,entitled, “Radio Frequency Identification Based (RFID) Sensor Networks,”any modified wireless device can be used. For example, in lieu of amodified cell phone an RFID reader can be used and may include thenecessary data processing, remote access and wireless link capabilitiespresent in devices such as a cell phone. Furthermore devices such as amodified wireless PDA, a modified wireless computer, a modified cordlessphone, a modified beeper or even a modified wireless watch may also becombined with RFID technology and be used as readers. In addition, asindicated above, the principles described in this application may beextended to technologies other than RFID. For example a cell phone thatis Bluetooth equipped may be used to communicate with and power a remotemodified wireless Bluetooth chip that is combined with the diagnosticsensor technologies described here.

Ideally the RFID electronic chip technology is fully compatible withinternational RFID readers and tag standards making the technologycompletely universal and transparent in any country or for any class ofRFID chip. At the present time these include Class 0, Class 0+, Class 1and Gen-2 standards. Emerging RFID standards are referred to asGeneration 2 or Gen-2 but other standards may emerge and be adopted inthe future. It is one of the objectives of this technology to becompatible with as many standards as possible so that a modified cellphone or PDA can read any given RFID tag or RFID sensor tag anywhere inthe world. A multi-protocol RFID reader can be used and be compressed ona single electronic chip or be directly incorporated into the corechipset of a cell phone or wireless device. For example, themulti-protocol reader technology can be included into a 3G electronicchip with the Bluetooth protocol so that any 3G device can read any RFIDelectronic product code (EPC) tag, RFID sensor tag or Bluetooth sensorchip transparently. The cell phone or personal wireless device hasremote access capabilities integrated therein. Thus a cellular telephoneuser can dial up any remote database or the Internet to access data fromthe RFID tag. In addition to having these capabilities and having RFIDreading capabilities, the device may have other Internet accessprotocols such as Bluetooth, Wi-Fi, Broadband, WLAN, 3G or otheremerging technologies that may allow free or low cost Internet access.Using these technologies will be particularly beneficial to fullyexploit the full potential of the present invention.

Patch 4 is typically attached to a subject (e.g., a person) but may alsobe attached to any location, device or object according to an embodimentof the present invention. In one embodiment, the stimulus may betemperature and the RFID tag and patch combination form a smart wirelesstemperature sensor. Accordingly, temperature can be directly measuredremotely on a modified cell phone that can be used to process RFID dataand warn a user of a wireless device about a temperature in a subjectremotely. The patch is therefore a “smart” patch and the wireless devicebecomes a “smart” device in combination with the RFID-sensor. An exampleof an application is a worker or a firefighter who can self-monitor himor herself for heat stress and/or toxic fumes using a cell phone withRFID read capabilities. If the cell phone is Bluetooth equipped, inaddition to doing sensor analyses, it may also send signals to both thefirefighter directly into his or her ear but also remotely to amonitoring station. In addition as explained in U.S. Pat. No. 6,031,454,that is incorporated herein in its entirety real time precisegeolocation of the firefighter is possible.

Another example of an application for this technology is remotemonitoring of a fever in a child or patient using a dedicated cell phoneor similar wireless device that can be used to call another cell phoneand warn a parent or a nurse of a temperature build-up in a givenpatient. For example a parent can place smart skin patch 4 on theforehead of a sick child and leave a device 2 to monitor the childremotely while the child and the parent are at sleep. If the childdevelops a fever during the night that reaches a pre-set thresholddevice 4 will automatically warn the parent and the warning may be donein any remote location. In one embodiment the smart patch is used inhospitals and can remotely monitor a number of patients simultaneously.With the recent FDA mandate that drugs be labeled with RFID tags, bothpatients, drugs and in fact anything can be monitored in real time in“smart” hospitals. The readers in a hospital allow geolocation andtherefore real time monitoring of the entire events in the hospital.Readers may also be directly connected to a network, thereby offeringgreat flexibility in the infrastructures that are used. In oneembodiment the temperature skin patch is a smart Band-Aid.

In another embodiment of the present invention the RFID tag and skinpatch combination includes a plurality of sensors that can be combinedfor different diagnostic applications that can be measured directly onthe surface of the skin, transdermally, in skin sweat, in blood drawndirectly onto a disposable skin patch. In another embodiment the skinpatch may also be used to measure external parameters such as physical,chemical or electrical parameters or a combination thereof on a patient.For example the RFID skin patch may be used to monitor the heart or beused to monitor external factors affecting the skin such as radiation.

FIG. 2 is a block diagram of a smart skin patch. As illustrated, patch 4has an RFID tag and sensor module 11. RFID tag and sensor unit 11combines an RFID tag with at least one sensor. Specifically, RFID tagand sensor module 11 includes an RFID electronic chip 10, a sensor 12,and at least one antenna 8. Typically the patch 4 is composed of a thinflexible support 5 that has an adhesive surface 7. Onto support 5 ismounted an antenna 8 typically composed of either a thin flexible metalfilm such as aluminum or material that is printed using doped inks orother flexible and highly conductive materials such as conductivepolymers. The antenna may be printed on the external surface of the skinpatch to avoid any possible skin contact or contamination.

Antenna 8 powers RFID electronic chip 10. In one embodiment RFIDelectronic chip 10 is passive. Alternatively, as recognized by one ofordinary skill, RFID electronic chip 10 may be active. In either case,RFID electronic chip 10 is typically located on a disk 6 that includesone or more sensors 12. RFID tag and sensor module 11 form an integratedunit on substrate disk 6. Disk 6 may be either a flexible substrate suchas a plastic or a rigid disk that includes different types ofsemiconductor sensors. For example disk 6 may include a combination ofan RFID tag and another low power sensor on a silicon substrate, wherebythe RFID tag serves as power and wireless unit and the sensor serves asthe sensing element. The term RFID tag refers to the combination ofantenna 8 and RFID electronic chip 10. Power may be stored into thepassive electronic chip by multiple cycles of external radio frequency(RF) energy. Using the combination of an RFID passive tag and energystorage capabilities complex sensors may be combined with RFID tagsdirectly on a disposable skin patch. These sensors do not need anyinternal power, are disposable and can be geolocated. Typically themanufacturing cost will be less than $1, resulting in great savings,convenience and improved safety.

Typically disk 6 and sensing elements 12 are protected by at least oneprotective layer 20. Accordingly, when patch 4 is positioned on theskin, layer 20 makes direct contact with the surface of the skin. Layer20 may be semi-permeable and may include specific chemistries that, incombination with the chemistries on each given sensor 12, aid in thedetection of specific chemical or biological elements. For exampleprotective layer 20 may filter certain proteins or cells and, at thesame time, prime the chemistries for specific reactions on the sensor orsensors according to one embodiment.

In addition disk 6 may also include more complex sensors that opticallydetect changes in blood chemistries and may include one or more diodescombined with sensors (not shown). For example small Schottky or backbias diodes may be used. Additionally using advances in polymers andother thin film technologies complex low power sensor-readercombinations may be printed or produced at very low cost. More complexsensors that are built directly on the electronic chip or an add-onelectronic chip may also be used in the smart skin patch.

The smart patch technology described here can therefore perform anynumber of different tests on a subject and be processed remotely by awireless device such as a cell phone. The wireless device provides notonly the power but also provides the means to analyze and process thesensor data on the spot. Therefore the processing requirements of theRFID tag and the sensing element are reduced, thereby reducing cost andpower requirements and making the technology disposable. The wirelessdevice can also provide step-by-step instructions to a user for eachgiven type of sensor. Since the RFID tag provides a unique ID to thewireless device this ID identifies uniquely the type of sensor used. Newclasses of RFID sensors may also become part of the emerginginternational RFID standards and have unique sensor identifiers. Thedata tables 68 are also capable of storing the identification number ofeach sensor. Additionally, the data tables 68 that analyze any givensensor may be stored on the chip, inside the cell phone or remotely.Therefore any cell phone can analyze on the spot any type of RFID EPCtag or RFID sensor tag, regardless of the manufacturer and as explainedmore fully in this invention.

FIGS. 3A and 3B illustrate different types of elements that can beincluded on skin patch 4. FIG. 3A describes one type of sensor 12. Inthis case a sensor surface 34 is surrounded by conductive electrodes 28.Typically both are directly printed or deposited on a non-conductivesurface 30. Methods for printing sensors are well known to those skilledin the art. As indicated above sensor surface 34 can be protected byanother chemical layer or physical-chemical barrier 32 that can helpfilter or eliminate certain elements or refine chemical reactions thatwill occur on sensor area 34. Multiple layers of barrier or reactivesurface 32 (not shown) can be used and can be layered one on top of theother serving as a method to separate different types of molecules andserving as reactive surfaces to absorb, eliminate or modify targetmolecules or reagents. Furthermore since disk 6 may be rigid, sensorsand separating layers may include metals, surfaces with nanopores or anyelement comprising a simple or complex multilayer sensor.

In addition different types of sensors can be used including sensorsserving as reference or calibration sensors. Since power is provided bythe passive RFID tag, any type of sensor or sensor combination can beused on the skin patch to respond to stimuli such as any type ofexternal chemical, electrical or physical changes that can occur on thesurface of the skin. It is recognized that responding to stimuliincludes any measuring, detecting, and/or reacting by the sensors.

Nevertheless, the orientation of disk 6 comprising the sensors mayeither face towards the skin or face away from it, depending on thegiven sensor application. In one embodiment the sensor may include amicroelectronic circuit that can include for example at least one adiode or other optical means to do complex sensor analyses. Such sensorsmay be necessary for some applications of the technology where moresimple sensing chemistries are not suitable. It will be appreciated thatsome of these sensors may be built directly into the RFID electronicchip itself. This includes for example a programmable temperature sensorbut may also include sensors that measure motion or small electricpulses on the skin. In one embodiment the skin patch is a cardiacsensor. In another embodiment the skin patch measures an external hazardto the skin or subject, such as radiation. In yet another embodiment theRFID skin patch includes a plurality of diagnostic sensors.

FIG. 3B shows disk 6 as an entire integrated unit that comprises acoiled antenna 8, RFID electronic chip 10, and multiple sensor elements12. The antenna can be mounted on one side of disk 6, while the sensorscan be mounted on the other side. Using this approach and according toone embodiment, the integrated unit can be directly mounted onto asupport 5 in a one step process.

FIG. 3C shows another embodiment of the present invention. In this caseskin patch 4 also includes a hard surface 40 that includes one orseveral micro knives 44 meant to help draw a drop of blood into thesensor areas (not shown). Applications of this technology may includeany diagnostic test where blood needs to be drawn. A disposable skinpatch with RFID sensors that includes the micro knives would simply needto be pressed slightly on the skin to draw sufficient blood for ananalysis causing minimal pain to the patient. The skirt patch may eveninclude a chemical to neutralize pain in the immediate area where bloodis drawn. Once the patch is applied to the skin a read of the sensor istaken from wireless device 2. In one embodiment this wireless test usingan RFID sensor is applied to blood glucose monitoring using a disposableRFID-skin patch and wireless device combination. If blood is drawn thesensor elements may include a filtering and separation mechanism (suchas a surface with micro or nanopores). Furthermore in another embodimentthe RFID sensing element may be separated from the blood drawing elementand is reusable. The sensor element may then be more complex and may beincluded for example directly into a watch.

In addition non-invasive methods to measure glucose levels or otherbodily chemistries may also be used and combined with RFID technologies.These include the use of diodes or other optical means that can detectoptical-chemical changes that occur.

FIG. 4 shows how a skin patch 4 that includes RFID tag technologies, theproper sensor chemistries and a mechanical device as described in FIG.3C can be used in case of diabetes self-monitoring and insulinself-regulation using a modified wireless device such as a modified cellphone 2. Data is obtained from a disposable skin patch and processed bythe microprocessor of a cell phone. In one embodiment the cell phone canthen control via RF a remote insulin pump 50 that can be implanted in abody. In lieu of using a separate glucose monitoring device, periodicglucose tests are done directly on a modified cell phone usingdisposable RFID-sensor skin patches. This way the patient does not needto use two devices and can check directly abnormal results with his/herdoctor in case of need. In some cases the skin patch may be reusableusing reversible reactions on the sensor surfaces. In one embodimentreversal occurs by micro heating the sensor area using power providedremotely by the wireless device. The implications of the invention shownin FIG. 4 is that any RFID or Bluetooth sensor can be read by a devicelike a modified cell phone that can also serve as a control system forother wireless technologies that are dependent on sensor values. Device2 may also allow direct remote monitoring of a given patient for otherfunctions, remote alerts and access to a physician's Office or medicalcenter. For example the device may monitor cardiac function on the smartskin patch, patient temperature, position, etc.

FIG. 5 shows the basic elements of the RFID electronic chip 10. RFIDelectronic chip 10 is coupled to antenna 8 that may include separatesend and receive elements (not shown). As discussed above, thecombination of RFID electronic chip 10 and antenna 8 is referred to asan RFID tag. Antenna 8 may be printed directly on a polymer or plasticsubstrate. The principles and operation of the RFID tag having a sensorinput is described in detail in U.S. patent application Ser No.10/761,362, filed Jan. 22, 2004, entitled, “Radio FrequencyIdentification Based (RFID) Sensor Networks,” which is incorporatedherein by reference in its entirety. Additional reference is also madeto U.S. Pat. No. 6,720,866 B1.

Antenna 8 is connected to a power unit 60 with a voltage stabilizationcircuit, a controller 62, an identification unit 64 (which may bepermanent or programmable), a memory unit 66, a sensor table 68, athermistor or temperature module/sensor 70, and analog to digitalconverter 72 and an optional filter 74. Preferably, the temperaturesensor 70 of the RFID electronic chip 10 is a very low power, highlyaccurate programmable unit that enables precise reference andcalibration points for any application of RFID tag and sensor module 11.In addition, the electronic chip 10 may include an energy storage unit(not shown) that stores energy for the power unit 60. This is importantfor sensors that exceed the available power to the passive chip. Thedevice may be a Class 0 electronic chip as described in U.S. Pat. No.6,002,344, a Class 0+chip, a Class 1 chip, a Gen-2 electronic chip orany other RFID or Bluetooth electronic chip that serves as a basicplatform and is modified to include a built-in precise temperature unit,a voltage stabilization unit, an A/D converter and the ability toincorporate at least one or a plurality of sensors that are thenincorporated into the devices described in this invention and form thebasis for passive RFID-diagnostic sensors that can be directly read bycommon low cost wireless devices such as modified cell phones. Using thepassive approach approximately 10 μwatts of power is available to thesensors from the RFID chip 10. Furthermore voltage can be preciselyregulated in the range of 1-5 volts, providing adequate power to mostdiagnostic sensors.

The RFID electronic chip 10 is attached to one or multiple externalsensors 12 that receive power and are controlled by units 60, 62, 72 and74. Sensors 12 and part of the electronic circuitry may be composed oflow cost doped inks or conductive polymers as described in U.S. patentapplication Ser. No. 10/382,606, entitled “Method and Apparatus for WideArea Surveillance of a Terrorist or Personal Threat,” which isincorporated herein by reference in its entirety.

FIG. 6 illustrates another embodiment of RFID tag and sensor module 11,which includes RFID electronic chip 10, antenna 8, a substrate 55,conductive leads 28, and a sensor element 12. For a number ofapplications, particularly diagnostic applications, at least onereference element 14 is used. In some applications the reference elementor the sensor may include at least one optional shield 16. In oneembodiment the shield 16 is a light shield that covers a radiationsensitive film to be used for a low cost radiation RFID tag and sensormodule 11 that may be included in a skin patch for a patient or may beused for Homeland Security or defense applications. In one embodimentboth the RFID tag and elements 14 and 16 serve as radiation detectors.Several types of radiation sensitive polymers or other thin filmmaterials may be used and be printed directly on the antenna substrate,creating a very low cost RFID passive radiation sensor. Since differenttypes of radiation sensitive materials may be used, both qualitative andquantitative radiation sensors can be produced at extremely low cost.Additionally radiation sensing diodes may be included directly in chip10, providing further low cost means to detect a radiation hazard.

In one embodiment sensor 12 is a chemical sensor. Therefore both lowcost chemical and radiation detectors can be included on a low costdisposable substrate that includes a wireless RFID tag and power unit.

FIG. 7 shows the applications of another type of novel RFID-sensortechnology combined with disposable flow-through assays to form adisposable wireless passive RFID immunoassay. Such assays can beincluded in disposable kits 90 where the power is provided remotely bythe low cost wireless device 2 and the analyses are also performed onsaid device or remotely via wireless links.

FIG. 8 describes the technology of FIG. 7 in more detail. A flow-throughimmunoassay testing strip 90 includes a sample input port 92 and asubstrate 94 that allows migration of the analyte on the assay bycapillary forces. The assay includes one or multiple test areas 96 thatare typically immobilized antibodies serving as a capture surface forspecific antigens that flow through the test surface. Such tests are nowcommonly used to test for pregnancy, for the presence of specificproteins or toxins and for the detection of specific pathogens such asStreptococcus. Recently with the discovery of disease-specificbiomarkers more complex tests are starting to become available. Howeverusing visual methods, such tests do not provide precise quantitativeresults and therefore is still generally limited to “yes” or “no” assaysindicating simply the presence or absence of a given protein orbio-analyte. While tests have improved greatly to the extent that theyhave now been placed in the hands of the public the quantification ofthe presence or absence of given proteins remains a highly desirablegoal. Such quantification can be now achieved by adding RFID orBluetooth technology as shown in the present invention. An RFIDelectronic chip 10 is added onto disposable device 90 and includesconductive leads 28 that go either to antenna 8 or to sensor areas 34.In order to avoid shorting electrodes 28 may be embedded into plasticleads 98 that can also serve as channels for the analyte flowing acrosssensor area 34. Printing of leads and channels can be done using ink-jettechnology or other similar means and is a low cost technology wellknown to those skilled in the art. Leads may also be laminated or moldeddirectly into plastic substrates. Other low cost assembly or productionmethods may also be used.

One of the test areas 96 may be a reference test area that measures theamount of moisture present on the surface or the presence or absence ofgiven proteins or other analytes. In some applications the surface hasto dry out before the results are read on the wireless device and thiscan be done automatically by using the reference strip or strips. Inaddition a window (not shown) may be used with a visual clue as to whenthe test is ready for analysis. For example if the test surface has todry out then a simple color change may be used with a hygroscopicmaterial that changes from red to blue depending on the level ofmoisture present on the RFID immunoassay strip.

Using this method many different channels and tests can be performedsimultaneously on a single disposable test strip. Furthermore thistechnology can be applied to different types of assays such aslateral-flow, flow-through or solid-phase assays or any assay where ananalyte is carried across a surface. The methods to fabricate the basicseparation surface are well known to those skilled in the art and mayinclude nitrocellulose or other similar materials.

FIG. 9 shows details of sensor area 34. Antibodies 100 are immobilizedonto substrate 94 using printing or other standard deposition methodsused for the fabrication of lateral-flow assays. As an analyte iscarried across the test strip by capillary action, matching antigens 104become attached to the antibodies. Such antigens could be proteins foundin blood or urine, proteins found on surfaces of pathogens or they couldbe other biological molecules. The technology can be applied to anysensor situation with specific surface-to-surface interactions. In oneembodiment this applies to proteins. In another embodiment to DNA orRNA. Hence disposable wireless RFID-sensor DNA assays that are readdirectly on a cell phone become possible with the technology describedin the application.

In order to allow conductivity between the two electrodes present in thesensor area, in some applications another layer of antibodies 106 can beadded which are specific to antigen 104. This technique is generallyreferred to as a “sandwich assay” and different methods exist to conductsuch assays. In this case instead of having dyes attached to theantibodies, conductive molecules 108 are attached forming a conductivelayer within sensor area 34. Conductive molecules can be conductivenanoparticles, conductive proteins, metal particles that are attached tothe protein or latex or other beads that are conductive. As indicatedabove if DNA or RNA is used then the conductive molecules can beattached directly then the matching DNA or RNA strands. The release ofthe conductive molecules 108 may be timed such that the assay is asimple, one step process.

In some applications the strip may need washing and drying before themeasurement are done. The state of the sensor can be assessedelectronically by using one or more reference test areas where thesensor consists simply of a material that absorbs water and thereforeallows for the saturation level and status of the entire test surface tobe measured. Such measurements can be done remotely by the cell phoneusing sensor data tables that are either stored on the RFID chip, on thememory of the cell phone or by downloading the correct sensor datatables from a remote location on the Internet or a remote locationavailable through the wireless networks. This method allow on the spotcomplex analyses to be performed.

Since the electrical conductivity of the surface area can be measuredprecisely quantitative results become possible on disposable wirelessRFID electro-immunoassays. Furthermore the test area can become verysmall allowing for more tests to be done in a given area and thereforeresulting in cost savings. In one embodiment the technology applies tohigh density DNA or RNA chips that are disposable.

In addition to the conductive methods described above, other methods maybe used that rely on RFID or Bluetooth as the basic low costcommunication and power platform for a disposable RFID immunoassay. Forexample optical means may be used to assess the presence and level of agiven protein. This is possible because the precise position ofdeposition of given antibodies is known and can match an optical reader.A dual system may be used where the disposable substrate with theprotein or DNA test is inserted into a reader (not shown) that comprisesan RFID power and communication module that can be read directly with adevice like a cell phone, PDA or computer in a doctors office.

Because it is low cost and is quantitative, the technology described inFIGS. 7-9 have broad market applications. In one embodiment it appliesto Homeland Security, where instant checks can be performed byprotective forces for example to confirm on-the-spot the presence orabsence of a given pathogen. In one embodiment the technology is appliedto food safety for the public. For instance using this technology traceelements can be detected in foods for people with certain allergies suchas peanut allergies. In one embodiment the technology applies to medicalself-tests for a given medical condition (e.g. a heart attack). In oneembodiment the technology applies to screening for a given medicalcondition such as a pre-cancer condition.

The technology may also be miniaturized and be applied to micro or evento nanosensors with very small sensor areas with the power provided andrelayed by a modified RFID or Bluetooth electronic chip to a remotewireless processing device such as a cell phone.

FIG. 10 shows the steps involved in the fabrication of disease-specificRFID wireless detection strips. Typically results from Genomics orProteomics research 111 yield pre-disease or early disease specificbiomarkers 112 associated with a given condition. Once these specificmarkers are identified, disease specific antibodies or surface receptors113 can be isolated. These are then integrated into disease-specificRFID sensors 114 resulting in a final disease-specific self-containedtesting kit 115.

Using the approach described in FIGS. 7-10 any specific disposablewireless RFID test strip can be produced. Since each RFID tag 10contains its own electronic identification number 64, wireless device 2can immediately recognize the type of sensor involved and perform thecorrect analysis. This is because a given modified cell phone candownload the necessary software, data tables, etc. from a remotelocation via a wireless link and can instantly become a “smart” devicefor any given type of RFID sensor. Furthermore since many differenttypes of tests can be performed at once on the same disposable wirelessplatform, cross validation and calibration is possible. Because of theremote data access and remote processing capabilities of the wirelessreader, the technology described here allows for ubiquitous sensing andanalyses for any type of RFID sensor using a single common wirelessplatform such as a modified cell phone. The RFID-sensors do not need touse a battery and are therefore very low cost. Furthermore for someapplications such as remote temperature monitoring the sensor is fullyreusable.

FIG. 11 shows the application of the technology for the measurement of anumber of different gases simultaneously using a single disposableRFID-sensor chip. As part of the antenna substrate 55 an area 110 iscomposed of a plurality of different sensors 12 with conductive leads28. Typically each sensor 12 is a different polymer or chemical that canreact differently with chemicals present in the air. Because the sensors12, the area 110 and the RFID electronic chip are on the same substrate,fabrication costs are very low and the entire unit comprising the area110 including sensors 12 can be assembled in a single step.

Area 110 is typically exposed to the air to allow chemical reactions totake place. In one embodiment the sensor is enclosed in a sealed pouch(not shown) that can be opened at a given time by a user of the sensorto test a given environment.

This “nose” technology and applications thereof is described in moredetail in pending patent application serial U.S. patent application Ser.No. 10/382,606, entitled “Method and Apparatus for Wide AreaSurveillance of a Terrorist or Personal Threat,” which is incorporatedherein by reference in its entirety.

FIG. 12 shows another embodiment of the present invention relating toPoint-of-Care or diagnostic technologies. Specifically it combineslab-on-the-chip (or LOC) technologies with RFID-sensor technology asshown in 118. Lab-on-the chip technology is well described in thescientific literature and consists of multiple microfluidic channels 124with either test, input or chemical wells 120. Reactions in wells 120can be measured using RFID technology since conductive leads 28 fromRFID electronic chip 10 can be linked directly to each of the test wells120. An antenna can be printed or mounted in another layer of theelectronic chip or directly on the back of the device. Furthermore theleads 28, the antenna and the electronic chip 10 can be embedded intothe LOC chip, thereby preventing shorting of the electrodes orelectronics. Since LOC allows complex sample separation and analyses,this technology allows LOC tests to be done independently of a complexor expensive reader. Rather a simple wireless device such as a cellphone or a PDA can be used. In one embodiment the cell phone alsocontrols the separation and control of the microfluidics channels 124for more complex LOC analyses. In one embodiment a LED and otherelectronic measuring or sensing devices are included in the LOC-RFIDchip. Therefore this technology is disposable and allows complex teststhat require separation and mixing to be placed directly into the handsof the public.

FIG. 13 shows how a LOC-RFID sensor unit 118 can be read directly from awireless device such as a cell phone, thereby bypassing the need for aLOC reader. In the case of LOC type analyses the data may be complex andexceed the processing capabilities of the low cost wireless reader. Inthis case the analyses can be performed remotely for example on a remotecomputer that can be accessed directly via a wireless link. For examplea centralized location may be provided with a direct dial in access thatis available to user of the cell phone. Other communications systems mayalso be used. For example, as indicated above, a Bluetooth equipped cellphone, PDA or other device that is also RFID compatible may have abuilt-in means to directly access the Internet.

FIG. 14 shows the integration of Micro Electro Mechanical System (MEMS)sensors 140 with RFID technology. In one embodiment, an RFID electronicchip 10 with conductive leads 28 is combined directly with a MEMS sensorproviding the power for the sensor. In one application MEMS sensor 140includes a resonating surface 148. Antenna leads 8 are only partiallyshown and typically do not form a part of the sensor area. In thisparticular case, the leads 28 are exposed to the air and therefore theapplications of the technology are more suitable for the detection ofgases. However, a number of different MEMS sensor configurations arepossible and only one is shown here. Because some MEMS sensors mayrequire more power than what is typically available on an RFID passivechip, the electronic chip may be modified to step up the voltage and/orto store the necessary current required to read MEMS-type sensors.Alternatively the sensor may include a battery.

FIG. 15 shows the integration of the RFID-sensor passive diagnostictechnology applied to foods. In this case the sensor unit 10 is includedinto a wine cork 150 for “smart wine” applications. In one embodiment,an RFID electronic chip with conductive leads 28 is mounted directlywithin the cork 150 while the antenna (not shown) is typically outsidethe bottle and may form a part of the wrapping at the top of the winebottle. The entire unit is inserted into wine bottle 155. In anotherembodiment the entire unit with the antenna forms a part of the cork. Ifthe chemistry of the wine changes, the cork will deteriorate because ofchanges in the acidity of the wine and this can be measuredelectronically externally with a wireless device such as a modified cellphone 2. Therefore prior to purchase by using a modified cell phone 2the consumer can immediately spot a bad wine bottle from a good one.Such applications are particularly relevant for expensive wines thatmust age for quite a while and are subject to many changes intemperature, etc. In another embodiment, the RFID tag technologydescribed herein can include a temperature module and a memory, theentire temperature storage profile of the wine can be recorded on theRFID passive tag and can be retrieved by the consumer on a cell phoneprior to purchase. If, for example, the wine was not stored properlythis will be known by the consumer. The temperature profile for thewines can be stored on the electronic chip by periodic “power up” cyclesor can be stored remotely and retrieved directly from a remote databaseusing the wireless device via a wireless link. Other power and storagemeans may also be used. Such applications are particularly relevant for“high end” wines.

FIG. 16 shows yet another embodiment of the present invention as appliedto other food items and in this case “smart” cheeses. Cheeses, likewines, can turn bad without the knowledge of the consumer and prior toopening the package. In this case a cheese 170 includes an electronicRFID label that also includes a sensor pad 176 with at least two sensors178 and 180. In FIG. 16 neither the antenna nor the RFID electronic chipare shown for the sake of simplicity. One sensor may be composed of ahygroscopic material to determine the moisture level of the cheese 170.The other may be a polymer that is sensitive or reactive to certainsmells associated with the aging or degradation of the cheese 170 as aresult of bacterial action. If the cheese 170 turns bad it is typicallybecause the moisture level is incorrect or because it has becomedegraded by bacterial action. By using several sensors a preciseassessment of the quality of the cheese can be assured remotely by theconsumer prior to purchase using a cell phone 2 with RFID readercapability. The type of sensor ID is matched with data tables andprocessing instructions that can be downloaded directly into the cellphone. See U.S. patent application Ser No. 10/761,362, filed Jan. 22,2004, entitled, “Radio Frequency Identification Based (RFID) SensorNetworks,” which is incorporated herein by reference in its entirety.

FIG. 17 shows a general printable passive RFID diagnostic food tagtechnology 202 that includes a sensor 204 that determines if the givenfood item has gone bad. The tag 202 is typically mounted in plastic andincludes an RFID electronic chip 10 and an antenna 8 mounted onsubstrate 55. Also included are conductive leads 28. In one embodiment,all areas except sensor 204, limited by area 206, are laminated inplastic or the body of the storage unit (e.g. milk carton) to avoidshortage of the electrodes or conductive leads 28. Therefore, thissensor can be included directly into a liquid or a food surface with ahigh level of humidity.

A sensor cap 208 is deposited on sensor area 204. Sensor cap 208contains a chemical that is specific to the food item and that becomesreactive only if the food turns bad. For example, the sensor tag can beincluded directly into meat packages on the surface of the meat itself.The RFID tag can contain all the information on the meat itself (price,date of packaging, etc.) but in this case the consumer will also be ableto determine the occurrence of bacterial contamination. This is becausesensor cap 208 can be made to be highly sensitive to enzymatic action byspecific bacteria. If a given type of bacteria is present on the surfaceof the meat they will start preferentially degrading sensor cap 208.Sensor cap 208 is typically waterproof and contains a doping substancethat will favor enzymatic degradation for each type of bacteria. Thiswill allow exposure of the electrodes and will change the conductivityon the surface of sensor area 204.

The same principles can be applied to any situation with a specificchemical interaction. For example the technology can be mounted directlyinside milk cartons. If milk has gone bad then its chemistry will changeand the change of chemistry can be tailored to specifically react withsensor cap 208. It will be appreciated that many different sensors canbe used with a single RFID chip, therefore allowing identification ofspecific types of bacteria. Furthermore, in another embodiment, thethickness of sensor cap 208 is varied in different sensors therebyallowing an assessment of the quantity of bacteria present. If morebacteria are present the sensor caps 208 will degrade faster and thethicker sensor caps 208 will degrade last. Therefore, this technologyprovides a general low cost solution for the food industry and combineselectronic RFID tag labeling with very low cost sensing technology.

FIG. 18 shows a diagnostic application of RFID passive sensors appliedto stresses. In this embodiment, an RFID-stress sensor 295 is providedthat is composed of two distinct parts. The first one forms a power andcommunication unit 290 that includes an RFID tag and an antenna 8. Unit290 is connected to a sensor 260 that includes attachment points 270,typically allowing a rigid mounting, stretchable leads 275 and aconnection area 280. Typically, connection area 280 is an easy “plug in”type to allow the user to easily mount the sensor onto any type ofsurface. Both components form a stress sensor unit 295.

The technology works as follows. Stress sensor 295 is firmly attached bya user through the use of attachment points 270. Stress sensor 295 maybe attached with skews or special glues to areas where possiblestructural stresses may occur and need to be measured remotely.Typically sensor 260 is composed of a thin film of a material such as aflexible metal strip that may be enclosed in a thin film of plastic (notshown). Any metals that are highly conductive and that can be stretchedmay be used such as aluminum, gold or copper. Area 290 is not attachedand therefore is not subject to the stresses. Conductivity measurementsare taken periodically via a remote wireless reader such as a cell phoneand stored in memory or on a remote database. Low cost wireless devicessuch as modified cell phones or RFID tag readers may be mounted close tothe sensors and are used to periodically monitor stresses. If stressesoccur the sensor 260 will expand. Since the temperature reference isknown, changes in the conductivity or resistance of the strip can beprecisely measured. Because this technology is wireless and has nobatteries, it is meant for long term monitoring in areas where visualaccess is difficult or not possible. This includes hidden structuralbeams in building, bridges, etc. but also any areas of high stresses(airplanes, homes, etc.). Stresses may also be monitored moredynamically with resonating MEMS structures or accelerometers asindicated in FIG. 14. A number of other methods may also be used such ascompression measurement using piezoelectric materials, loss ofconductivity in leads that break or snap as a result of stresses, etc.Broad market applications exist for the technology, for exampleinsertion of a wireless RFID sensor in windows for “smart” homeapplications, etc.

FIGS. 19A and 19B show yet another application of the technology appliedto an RFID-insect sensor such as a termite sensor. In FIG. 19 A theentire sensor unit is enclosed in a unit 310 that is highly attractiveto termites such as a block of wood. Unit 310 can form a “plug” of astandard size that is inserted into structural wooden supports. The unitcomprises an antenna 8, an RFID electronic chip 10 and leads that areshown in more detail in FIG. 19 B.

FIG. 19B shows the details of the technology in one embodiment.Conductive leads 28 are separated by a spacer 320 that is made ofnon-conductive material that is highly attractive to termites such aswood. If termites are present then spacer 320 will be eaten and thespacer separating electrodes or leads 28 will disappear. Electrodes 28may be forced together by a spring (not shown). When the spacer hasdisappeared the electrodes short out and therefore it is known thattermites are present. In case electrodes such as shown in FIG. 19B areused a mounting power unit similar to 290 (FIG. 18) may be used. Othersimple conductive methods may be used for this type of sensor.

Because this is a low cost wireless technology with no batteries, thetechnology can be used in hidden areas such as structural supports inhouses, etc. The technology can be used to monitor remotely any type ofinsect damage, or may even be applied to pathogens such as bacteriausing surface-specific materials that degrade only in the presence ofcertain enzymes.

FIG. 20 shows the uses of the technology for drug interaction testing orfor general medical self-testing for any given condition. In oneembodiment after drug 360 is taken a disposable wireless RFID sensorstrip 90 is placed in a urine sample 364. Such strips may be providedfor free with given drugs where certain toxicities may occur as a resultof combination with other drugs. Using a low cost wireless device suchas a cell phone 2 with RFID multi-protocol reader capability, complexdrug interaction tests can be performed on-the-spot at a very low cost.This is possible by wireless access to cell phone towers 380, access toInternet 390 and to a remote storage/data processing unit 400. In oneembodiment remote storage/data processing unit 400 is embodied as acomputer or electronic database. Accordingly through the use of computer400 (hereinafter remote storage/data processing unit 400 shall bereferred to as computer 400), a patient can either download data tocomputer 400 or upload into the cell phone the necessary information toconduct any given test by matching the ID of the RFID sensor with givensoftware and data tables stored remotely on computer 400 via link 392.In one embodiment computer 400 is a computer in a doctor's office. Inanother embodiment computer 400 is a drug interaction database of apharmaceutical company. In yet another embodiment computer 400 is acomputer containing reference tables for all types of RFID sensors.Since the RFID identifies each test uniquely a match of data, analysesprotocols and/or software is assured. The principles described in thisembodiment extend well beyond drug testing. By using disposable RFIDtest strips 90 with specific receptors to specific biomarkers, tests canbe performed for any medical condition directly by a patient using awireless device such as a modified cell phone. As biomarker discoverybecomes more refined common wireless technologies can become used forself-diagnostics for almost anything using low cost wirelesstechnologies such as cell phones. Such low cost diagnostic tests will beimportant in settings where sophisticated laboratory equipment is notavailable but where cell phone technology is available. The use of thetechnology described in this embodiment may be particularly relevant forless-developed countries where sophisticated laboratory equipment is notalways available locally.

FIG. 21 shows the general applications of passive diagnostic RFIDsensors to wireless sensor networks and wireless devices, wirelessgeolocation, the Internet, remote database access, remote data storageand remote data analyses. Specifically as described in this applicationa passive RFID diagnostic tag 10 can be used to identify any givenhazard 460 in any given location. Wireless tag 10 can be activated bywireless device 2 via a wireless link 480. The microprocessor and RFIDreader within wireless device 2 enable processing functions 500, whichinclude reading, analysis and geolocation by a global positioning system(GPS) or a non-GPS means. The reading, analysis and geolocation by GPSor non-GPS means is described in U.S. Pat. No. 6,031,454 that isincluded herein by reference in its entirety. Wireless device 2 cancommunicate to a proximal cell phone tower or receiver 380 via wirelesslink 510 or indirectly by other existing or emerging wirelesscommunication means such as Bluetooth. Cell phone tower 380 is linked tothe Internet 390 or the wireless networks via soft or hard links 520 andto at least one remote computer 400 via soft or hard link 540. Remotecomputer 400 allows the functions 550, including the storage of RFIDtables and associated software to analyze on the spot any givendiagnostic RFID sensor tag 10. In addition using soft or hard links 630any remote wireless device 600 may be used providing the functions 620allowing remote access of any given RFID sensor tag via wireless device2.

The implications of FIG. 21 are the following. Any wireless device 600in any given geographical location can interrogate any given RFID-sensor10 in another location. Sensor 10 may be a plurality of diagnosticsensors. For example a simple application is the following. Sensor 10may be a temperature sensor located in a second home and include a smartsticky patch that is placed on a pipe. The owner of the home can checkremotely the temperature in the home from any given location todetermine for example if pipes are at risk of freezing. Two-wayfunctionality is built into device 2. That is device 2 can be programmedto dial or send data remotely or be activated and queried at any timefrom any location.

FIG. 22 explains in more detail the functions in FIG. 21 and thosedescribed in this invention. Any RFID wireless reader can be used toread a compatible RFID passive sensor but a clear improvement is to usea multi-protocol reader (such as a Gen-2 enabled reader). A furtherimprovement is to put the multi-protocol reader capability directly on asingle chipset and most preferentially this chipset is the coreelectronic chip of a common wireless device such as a cell phone. Itwill be clear to those skilled in the art that the reader capability mayalso be integrated on a separate electronic chip that can be included ina computer as part of a plug-in smart card or even an RFID reader deviceconnected to or built-in a Universal Serial Bus (or USB) port or similarconvenient connection means. Such a device is most useful for examplefor a physician's office where the diagnostic functions of passive RFIDdiagnostic sensors described here can be fully exploited. In additionthe devices described here may be compatible with Bluetooth, Zigbee orother emerging technologies, allowing further flexibility.

For consumer applications interrogation of any given RFID tag can beperformed easily on a modified cell phone that includes either a specialRFID read button or by pressing a series of existing keys on a keypad.Once a given tag is activated, the reader device can retrieve the IDnumber of the tag as shown by function 700. The reader may or may notinitially recognize the tag as shown in FIG. 708. If the newinternational standards are adopted for RFID sensor tags then suchrecognition will be standard and can be integrated with either the tagitself and/or a data table in the reader 2. If the ID of the sensor tagis recognized then the reader device may or may not have the necessarysoftware and processing ability to analyze said sensor as shown in 716.If the software is available then the analysis can be completedimmediately as shown in 746. However if the software is not availablethen the device must first obtain it from a given remote database 400via function 720. This may be a centralized database for RFID tags or adiagnostics database that is accessed only by paying an access fee.Subsequently, the ID of the RFID sensor is matched to a given class ofsensor (e.g. a glucose sensor) and the software and/or instructions forthe analyses are downloaded into the reader 2 as shown in function 738.The device is then equipped to perform the analysis 746. Additionalcommunication with computer 400 may occur if the analyses are complex(e.g. neural net or multivariate) and exceed the processing capabilitiesof the reader. Results are subsequently displayed on the cell phone orreader as shown in 758. Alternatively results may be displayed or storedremotely (e.g. in a doctor's office, etc.). The pathway described aboveis not limited to passive RFID diagnostic sensors. It can also includeEPC tags, other RF tags or sensors such as Bluetooth and other wirelessfunctions such as smart shopping or “smart wallet”.

FIG. 23 shows the integration of the two types of sensor readerfunctions into a single wireless reader and a resulting new type ofwireless chipset that can be included into any wireless reader. Startingwith device 800 and as explained in U.S. Pat. No. 6,031,454 and PatentApplication US 2004/0119591 A1 by the present inventor that areincorporated by reference in their entirety, a wireless device such as acell phone may be modified to accommodate any number of sensors 816,including diagnostic sensors. These are typically “active” sensors sincethey are directly connected to the wireless device itself. An example ofthis is a cell phone that is also a person-specific asthma detector asdescribed in Patent Application US 2004/0119591 A1. In addition to thiscapability, any wireless device 2 such as a cell phone may also bemodified to interrogate remotely any active or passive wireless sensor 4as described in this application. This capability most preferentially isa multi-protocol capability and includes emerging standards such asGen-2, other future international standards for RFID and Bluetooth.

The cell phone may already have other multi-functionality integratedtherein (such as Internet access). A widely adopted emerging standard isreferred to as Third Generation or 3G functionality that is includeddirectly into the chipset.

In this invention the ability to read any “plug-in” sensor and anyremote wireless sensor are combined in 850 and results in a newmulti-function chipset that allows any wireless device to read anysensor, whether a “plug-in” sensor or a remote wireless sensor. Mostpreferentially these capabilities are included into the core wirelesselectronic chip (such as the 3G chip), thereby extending thecapabilities of the wireless device to read and analyze instantly anytype of sensor, RFID tag, RFID-sensor tag or Bluetooth sensor,regardless of the manufacturer, location or nature of the sensor.

As described in the above embodiments, wireless passive RFID sensors canbe used for many different types of diagnostic applications in theconsumer markets, defense and Homeland Security, building securityindustry, medical diagnostics industry, food safety industry, and forhome safety and other applications using a common wireless device suchas a modified cell phone. This technology provides great convenience toconsumers, to workers or to any person concerned with the detection ofexternal threats or having special medical needs or concerns.

The diagnostic sensor technologies described here can also be adapted tonetworks and to national emergencies, where tagged items can be readremotely (thousands of feet), by employing special high power readers.

While various embodiments of the present invention have been describedabove, it should be understood that they have been presented by way ofexample only, and not limitation. It will be apparent to persons skilledin the relevant art that various changes in form and detail can be madetherein without departing from the spirit and scope of the invention.Thus, the breadth and scope of the present invention should not belimited by any of the above-described embodiments, but should be definedonly in accordance with the following claims and their equivalents.

1. A diagnostics system comprising: a flexible patch having an adhesiveportion and adapted to be positioned on a surface; a radio frequencyidentification (RFID) tag and sensor module integrated with said patchand having an antenna, an RFID electronic chip, and at least one sensor,said RFID tag and sensor module responding to a stimulus by wirelesslytransmitting and receiving, through the use of said antenna, signalsthat correspond to said stimulus; and a wireless RFID reader adapted tocommunicate through the use of multiple protocols with said RFID tag andsensor module, said RFID reader being adapted to communicate over anetwork through the use of multiple communication protocols.
 2. A systemaccording to claim 1, wherein a substantial portion of said RFID tag andsensor module is integrated onto a substrate disk.
 3. A system accordingto claim 2, wherein said substrate disk includes a protective layerattached thereto, said protective layer being in direct contact with thesurface when said patch is positioned on the surface.
 4. A systemaccording to claim 3, wherein said protective layer is formed of asemi-permeable material that is adapted to react to said stimulus fromsaid surface.
 5. A system according to claim 1, wherein said RFID tagand sensor module comprises: a sensor interface having an analog todigital converter coupled to said at least one sensor; and a controllercommunicative with said sensor interface, said controller having amemory with a sensor data table being adapted to analyze said at leastone sensor within said RFID tag and sensor module.
 6. A system accordingto claim 5, wherein said controller stores a sensor identificationnumber in said sensor data table.
 7. A system according to claim 5,further comprising a temperature sensor communicative with saidcontroller.
 8. A system according to claim 1, wherein responding to saidstimulus includes sensing electrical, chemical, biological, and physicalelements of said surface.
 9. A system according to claim 1, wherein saidRFID reader is selected from the group consisting of a cellulartelephone, a personal digital assistant, a beeper, and a computer.
 10. Asystem according to claim 1, wherein said surface is the skin surface ofa person.
 11. A system according to claim 1, wherein said RFID tag andsensor module further comprises a power unit adapted to stabilizevoltage within said RFID tag and sensor module.
 12. A system accordingto claim 1, wherein said patch includes at least one micro knife adaptedto draw blood from said surface when said patch is pressed on saidsurface, wherein said surface is the skin surface of a person.
 13. Asystem according to claim 1, wherein said RFID tag and sensor module isformed as an integrated circuit.
 14. A system according to claim 1,wherein said patch comprises: a substrate having a sample input portenabling migration of an analyte by capillary forces; and at least onetesting area integrated with said substrate area and adapted to captureantigens that flow through said testing area.
 15. A system according toclaim 1, wherein said at least one sensor is a glucose sensor.
 16. Asystem according to claim 1, wherein said at least one sensor is acardiac sensor.
 17. A system according to claim 1, wherein said at leastone sensor is a radiation sensor.
 18. A system according to claim 1,wherein said RFID tag and sensor module includes at least one attachmentpoint that enables attachment of the RFID tag and sensor module to astructural stress, thereby forming a RFID stress sensor.
 19. A systemaccording to claim 1, wherein said patch is disposable.
 20. A systemaccording to claim 1, wherein said RFID sensor further includes a powergeneration module that powers said RFID sensor.
 21. A system accordingto claim 1, wherein said network includes a remote storage and dataprocessing unit adapted to remotely store and analyze data read by saidRFID reader.
 22. A system according to claim 1, wherein said RFID readerincludes a microprocessor adapted to analyze and geolocate said patch.23. A system according to claim 22, wherein said geolocation occursthrough the use of a global positioning system.
 24. A system accordingto claim 1, wherein said RFID tag and sensor module is integrated intoan immunoassay testing strip.
 25. A human diagnostics system comprising:a patch having a radio frequency identification (RFID) tag and sensormodule, and being attachable to the surface of the skin and adapted tosense predetermined elements through the skin and transmit signalscorresponding to said predetermined elements; a RFID readercommunicative with said patch through the use of a network and adaptedto analyze, receive, and transmit the signals from said patch throughthe use of multiple protocols; and a remote storage and data unitcommunicative with said RFID reader, said remote storage and data unitanalyzing and storing data from said patch and said RFID, said remotestorage and data unit transmitting said analyzed and stored data to saidRFID reader through the use of said network.
 26. A system according toclaim 25, further comprising a remote wireless device adapted toremotely access said predetermined elements sensed by said RFID tag andsensor module.
 27. A system according to claim 25, wherein saidpredetermined elements include electrical, chemical, biological, andphysical elements of a person.
 28. A system according to claim 25,wherein said network is a wireless network that enables communicationthrough the use of a communication protocol including, Bluetooth, Wi-Fi,Broadband, WLAN, and 3G.
 29. A system according to claim 25, whereinsaid RFID reader is a cellular telephone.
 30. A personal wirelesscommunications device for communicating with a radio frequencyidentification (RFID) tag and sensor module, comprising: a multiprotocol RFID reader that is compatible with and adapted to activatesaid RFID tag and sensor module; a microprocessor communicative withsaid RFID reader and adapted to analyze and store data read by said RFIDreader; and at least one antenna coupled to said microprocessor fortransmitting and receiving data from said RFID reader, saidmicroprocessor and said RFID tag and sensor module, said antenna beingadapted to transmit and receive data from an external device through theuse of a network.
 31. A device according to claim 30, wherein said multiprotocol RFID reader, said microprocessor, and said antenna, areintegrated into a cellular telephone.
 32. A device according to claim30, wherein said microprocessor is adapted to determine the location ofsaid RFID tag.
 33. A device according to claim 30, wherein said multiprotocol RFID reader, said microprocessor, and said antenna, areintegrated into a personal digital assistant (PDA).
 34. A deviceaccording to claim 30, wherein said external device is a remotestorage/data processing unit adapted to analyze, store, and transmitdata received from said antenna.
 35. A diagnostics system comprising: apatch having an adhesive portion and adapted to be embedded within astructure; a radio frequency identification (RFID) tag and sensor modulehaving an integrated temperature module, said RFID tag and sensor modulebeing integrated with said patch and having an antenna and at least onesensor, said RFID tag and sensor module responding to a stimulus bywirelessly transmitting and receiving, through the use of said antenna,signals that correspond to said stimulus; and a wireless RFID readercommunicative with said RFID tag and sensor module, said reader beingadapted to communicate over a network through the use of multipleprotocols.
 36. A system according to claim 35, wherein said stimulus isa defect in said structure.
 37. A system according to claim 35, whereinsaid stimulus is the presence of insects within said structure.
 38. Animmunoassay test strip system for use in conducting diagnosticmeasurements comprising: a substrate that forms a test strip; at leastone test area located on said substrate for capturing antigens; and aradio frequency identification (RFID) tag and sensor module integratedwith said substrate, said RFID tag and sensor module being adapted tosense and transmit signals that correspond to the antigens captured bysaid at least one test area.
 39. An immunoassay test strip according toclaim 38, further comprising a wireless reader adapted to receive andprocess signals from said RFID tag and sensor module through the use ofmultiple protocols.
 40. An immunoassay test strip according to claim 39,wherein said wireless reader is a cellular telephone.
 41. An immunoassaytest strip according to claim 38, wherein said RFID tag and sensormodule includes a temperature sensor.
 42. An immunoassay test stripaccording to claim 38, wherein said test strip is disposable.
 43. Animmunoassay test strip of claim 38, wherein said test strip is adaptedto perform quantitative protein measurements.
 44. An immunoassay teststrip of claim 38, wherein said test strip is adapted to performquantitative biomarker measurements.
 45. An immunoassay test strip ofclaim 38, wherein said test strip forms a disease-specific sensordevice.
 46. An immunoassay test strip of claim 38, wherein said teststrip is adapted to perform pre-disease specific tests.
 47. Animmunoassay test strip of claim 38, being adapted to perform drugtoxicity tests.
 48. A method of manufacturing a pathogen-specific radiofrequency identification (RFID) tag and sensor module, comprising thesteps of: providing a substrate; printing conductive leads on saidsubstrate wherein said conductive leads define a sensor area; printing aprotective cap doped with a material that is sensitive topathogen-specific enzymatic action within said sensor area; printing anantenna on said substrate; and integrating an RFID tag and sensor modulewith said substrate.
 49. A multi-function personal wirelesscommunications device capable of wireless diagnostics throughcommunication with at least one radio frequency (RF) addressable sensorhaving a radio frequency identification tag and sensor unit, comprising:a user interface for receiving an input from a user and transmittingsignals corresponding to said input; a multi-protocol RF reader adaptedto receive said input signal, said RF reader adapted to retrieve aunique identification of the RF addressable sensor and downloadingsoftware that enables reading and analyses of the RF addressable sensor;a controller having memory storage and being adapted to process andtransmit signals received by said RF reader; and at least one antennaconfigured to receive signals from the RF addressable sensor andtransmit signals from said controller and said RF reader.
 50. Themulti-function personal wireless communications device of claim 49,wherein said communications device is adapted to geolocate the at leastone RF addressable sensor.
 51. The multi-function personal wirelesscommunications device of claim 49, wherein the wireless communicationsdevice is a cellular telephone.
 52. The multi-function personal wirelesscommunications device of claim 49, wherein said multi-protocol RF readerdownloads software that enables reading and analyses of the RFaddressable sensor from a remote database.
 53. The multi-functionpersonal wireless communications device of claim 49, wherein the deviceis a PDA.
 54. The multi-function personal wireless communications deviceof claim 49, wherein said user interface includes a preconfigured buttonfor initiating a read of the RF addressable sensors.
 55. Themulti-function personal wireless communications device of claim 49,further comprising a means for receiving sensor processing informationover the communications network.
 56. The multi-function personalwireless communications device of claim 49, further comprising a meansfor connecting a removable sensor module; wherein said removable sensormodule provides at least one sensor with a means for monitoring a givenhealth function or for detecting the presence of a harmful agent in theatmosphere.
 57. The multi-function personal wireless communicationsdevice of claim 56, wherein the controller, network communicationsmeans, RF addressable sensor communication means, removable sensor meansand user interfaces are integrated onto a single electronic chip. 58.The multi-function personal wireless communications device of claim 57,wherein said single electronic chip is a 3G chipset.
 59. A Lab-on-a-Chipmicrofluidics sensor for conducting rapid diagnostic measurements thatare readable directly with a remote wireless RF reader comprising:conductive leads that enable transmission of signals; a Lab-on-a-Chipsubstrate having at least one test area integrated therein and a sensorinterface that couples said conductive leads to said test area; atemperature module integrated with said substrate and adapted togenerate signals that correspond to temperature; an addressable radiofrequency (RF) chip having a controller, an RF power source with avoltage stabilization circuit, and a communication interface, said RFchip receiving signals from said conductive leads and said temperaturemodule, said RF chip being adapted to process said conductive leadsignals, said temperature module signals and signals from the wirelessRF reader; and at least one antenna adapted to receive signals from thewireless RF reader and said RF chip and transmit signals from saidLab-on-a-Chip microfluidics sensor.
 60. The Lab-on-a-Chip device ofclaim 59, wherein the microfluidics sensor is capable of quantitativeprotein measurements that are readable directly with the wireless RFreader.
 61. The Lab-on-a-Chip device of claim 59, wherein themicrofluidics sensor is capable of quantitative biomarker measurementsthat are readable directly with the wireless RF reader.
 62. TheLab-on-a-Chip device of claim 59, wherein the microfluidics sensor isadapted to perform DNA tests that are readable directly with thewireless RF reader.
 63. An immunoassay test strip for conducting aninstant diagnostics test using a wireless reader device, wherein thewireless reader device is adapted to communicate over a wirelessnetwork, the immunoassay test strip comprising: at least one test areawith an integrated radio frequency chip that is communicative with thewireless device and that provides power to said test area; and whereinsaid test area is an electro-immunoassay for measuring the presence andquantity of a biological molecule.
 64. An immunoassay test stripaccording to claim 63, wherein said radio-frequency chip is selectedfrom the group consisting of an RFID chip, a Bluetooth chip, a Zigbeechip or an IEEE 1073 chip.